Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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primaLOK FF 40mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1140-00
In Commercial Distribution

  • 00813210021983 ()

  • Length: 40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 30mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1130-00
In Commercial Distribution

  • 00813210021969 ()

  • Length: 30 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00755
In Commercial Distribution

  • 10873263007553 ()
  • 00873263007556 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
  • Length: 234.2 Millimeter
  • Length: 249.2 Millimeter
FC5000

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00752
In Commercial Distribution

  • 10873263007522 ()
  • 00873263007525 ()

  • Length: 227.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Length: 242.2 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2004

  • Depth electrode
microTargeting Differential Electrodes 5x, Sterile, Single and Array, DZAP(L), T=30 for use with Nexframe and STar Drive
FHC, INC.
FC2004-00129
Not in Commercial Distribution

  • 10873263001292 ()
  • 00873263001295 ()

  • Length: 227.2 Millimeter
  • Length: 242.2 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.56 Millimeter
  • Length: 10 Millimeter
FC2004

  • Depth electrode
microTargeting(TM) Electrodes, 5x, Sterile, Single or Array, 1 Meg, for use with NexFrame and mT Drive or NexDrive.
FHC, INC.
FC5000-00117
Not in Commercial Distribution

  • 10873263001179 ()
  • 00873263001172 ()

  • Length: 249.2 Millimeter
  • Length: 10 Millimeter
  • Length: 234.2 Millimeter
  • Impedance: Megaohms
  • Length: 0.56 Millimeter
FC5000

  • Depth electrode
microTargeting Differential Electrode 5x, Sterile, Single and Array, D.ZAP(L) , T=30 for use with NexFrame and MT Drive or NexDrive
FHC, INC.
FC2003-00751
In Commercial Distribution

  • 10873263007515 ()
  • 00873263007518 ()

  • Length: 10 Millimeter
  • Length: 249.2 Millimeter
  • Length: 234.2 Millimeter
  • Outer Diameter: 0.56 Millimeter
  • Impedance: Megaohms
FC2003

  • Depth electrode
microTargeting D.ZAP(L) Differential Electrode 5x, Sterile, Single, T=30 for use with Frame and STar or MT Drive
FHC, INC.
FC2002-00750
In Commercial Distribution

  • 10873263007508 ()
  • 00873263007501 ()

  • Length: 10 Millimeter
  • Impedance: Megaohms
  • Length: 271.4 Millimeter
  • Length: 256.4 Millimeter
  • Outer Diameter: 0.77 Millimeter
FC2002

  • Depth electrode
microTargeting Differential Electrode 5x, D.ZAP(L), Sterile, Array, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC2001-00749
In Commercial Distribution

  • 10873263007492 ()
  • 00873263007495 ()

  • Length: 276.5 Millimeter
  • Outer Diameter: 0.55 Millimeter
  • Length: 261.5 Millimeter
  • Length: 10 Millimeter
  • Impedance: Megaohms
FC2001

  • Depth electrode
microTargeting Electrode 5x, non-sterile, Array, 1 Meg, T=30 for use with Frame, STar or MT Drive
FHC, INC.
FC1003-00748
In Commercial Distribution

  • 10873263007485 ()
  • 00873263007488 ()

  • Length: 10 Millimeter
  • Length: 276.5 Millimeter
  • Length: 261.5 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 0.55 Millimeter
FC1003

  • Depth electrode
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